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- Tasks: Manage clinical trials, ensuring quality and compliance while collaborating with diverse teams.
- Company: AstraZeneca, a leader in the pharmaceutical industry committed to diversity and inclusion.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by leading innovative clinical studies.
- Qualifications: Bachelor’s degree in a relevant field and 3-4 years of clinical trial experience.
- Other info: Join a dynamic team that values diverse perspectives and fosters career development.
The predicted salary is between 36000 - 60000 £ per year.
Global Study Manager
Duration – 12 months (interim)
Location – Remote
Inside IR35
The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.
Responsibilities:
• Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
• Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
• Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
• Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
• Support risk management and quality efforts to ensure study compliance.
• Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
• Prepare presentation material for meetings, newsletters and websites.
• Support the study team in the implementation of audits and regulatory inspections.
• Contribute to review of new/amended/unique SOPs and guidance documents.
Essential Skills/Requirements:
University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
• Minimum of 3-4 years of progressive clinical trial experience
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Excellent knowledge of ICH-GCP principles
• Demonstrated verbal and written communication skills
• Early Phase experience (phase I and IIa)
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements
Clinical Trial Manager employer: AstraZeneca
Contact Detail:
AstraZeneca Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trial Manager
✨Network Like a Pro
Get out there and connect with people in the industry! Attend virtual events, join relevant LinkedIn groups, and don’t be shy about reaching out to professionals. You never know who might have the inside scoop on job openings or can refer you directly.
✨Ace the Interview
Prepare for your interviews by researching the company and understanding their clinical trial processes. Practice common interview questions and think of examples from your experience that showcase your skills. Remember, confidence is key!
✨Follow Up
After an interview, send a quick thank-you email to express your appreciation for the opportunity. It’s a great way to keep yourself top of mind and show your enthusiasm for the role. Plus, it’s just good manners!
✨Apply Through Our Website
Don’t forget to check out our website for the latest job openings! Applying directly through our site can sometimes give you an edge, as we prioritise candidates who show genuine interest in our company. Let’s get you that dream job!
We think you need these skills to ace Clinical Trial Manager
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Clinical Trial Manager role. Highlight your relevant experience in clinical trials and any specific skills that match the job description. We want to see how you fit into our team!
Showcase Your Experience: When detailing your work history, focus on your achievements in previous clinical trial roles. Use specific examples that demonstrate your ability to manage studies, work with vendors, and ensure compliance. This helps us understand your impact in past positions.
Be Clear and Concise: Keep your application straightforward and to the point. Avoid jargon unless it’s relevant to the role. We appreciate clarity, so make it easy for us to see why you’re a great fit for the position!
Apply Through Our Website: Don’t forget to submit your application through our official website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it keeps everything organised on our end!
How to prepare for a job interview at AstraZeneca
✨Know Your Stuff
Make sure you brush up on your clinical trial knowledge, especially ICH-GCP principles. Familiarise yourself with the specific responsibilities of a Global Study Manager and be ready to discuss how your experience aligns with these tasks.
✨Showcase Your Flexibility
Since the role requires a high degree of flexibility, prepare examples from your past where you've successfully adapted to changing circumstances or requirements in clinical studies. This will demonstrate your ability to thrive in dynamic environments.
✨Vendor Management Insights
Be ready to talk about your experience with third-party vendors. Discuss how you've managed budgets, contracts, and vendor relationships in previous roles, as this is crucial for the position.
✨Communication is Key
Highlight your verbal and written communication skills during the interview. Prepare to share examples of how you've effectively communicated with study teams, regulatory bodies, and other stakeholders to ensure compliance and quality in clinical trials.